UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058716 |
|---|---|
| Receipt number | R000067136 |
| Scientific Title | The effect of a digital behavioral intervention for smartphone addiction among university students: A randomized controlled trial |
| Date of disclosure of the study information | 2025/12/31 |
| Last modified on | 2025/10/10 14:10:06 |
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Basic information
Public title
Digital Solution for Reducing Smartphone Overuse in Chinese College Students
Acronym
DiSReSCO
Scientific Title
The effect of a digital behavioral intervention for smartphone addiction among university students: A randomized controlled trial
Scientific Title:Acronym
DBISA-RCT
Region
| Asia(except Japan) |
Condition
Condition
Smartphone usage addiction or dependence
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will implement a psychological-behavioral intervention combining compassion-focused therapy and implementation intentions for Chinese university students with problematic smartphone use and mental health problems, examining both its effectiveness and underlying mechanisms.
The process does not involve the use of drugs and clinical operations.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological questionnaires will be used to measure the primary outcomes, which consist of two main result. These outcomes will be assessed using the Smartphone Addiction Scale Short Version and the Patient Health Questionnaire 9, both of which are widely used tools that have been shown to not negatively impact respondents.
Key secondary outcomes
The secondary outcomes will also be measured using tools that possess psychometric validity and have been shown not to negatively impact respondents. The questionnaires employed include the following:
The 8-item version of the Barratt Impulsiveness Scale-11 for measuring impulsivity.
The Short version of the Cognitive Emotion Regulation Questionnaire to assess cognitive emotion regulation.
The Family and Peer Support Questionnaire for evaluating interpersonal relationships.
The Revised Personal Relative Deprivation Scale to measure relative deprivation.
The Brief Self-Control Scale for assessing self-control.
These are the secondary outcomes currently planned, with the possibility of adding more questionnaires in the future.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
CFT+II group:
This group employs compassion-focused therapy and implementation intention strategies to address problematic smartphone use and mental health concerns among Chinese university students. Participants receiving the intervention will be provided with specially designed video and text materials lasting approximately one hour.
Interventions/Control_2
Only II group:
This group employs implementation intention strategies to address problematic smartphone use and mental health concerns among Chinese university students. Participants receiving the intervention will be provided with specially designed video and text materials lasting approximately half hour.
Interventions/Control_3
Active control group:
The participants in this group only receive health information only.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1:aged 18 years or older
2:Score greater than 33 for females and 31 for males on the smartphone Addiction Scale short version
3:Score greater than 2 on the Patient Health Questionnaire-4 scale
4:able to provide informed consent
Key exclusion criteria
1:presence or history of neurologicalor neurodegenerative disorder
2:sensory impairments (e.g., vision or hearing problems) that preclude assessments
3:having a diagnosis of intellectual disability (IQ<70) or a pervasive developmental disorder (e.g., autism spectrum disorder)
4:having a current diagnosis of substance use disorder (excluding Cannabis and Tobacco in the past months).
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Rui |
| Middle name | |
| Last name | She |
Organization
The Hong Kong Polytechnic University
Division name
Department of Rehabilitation Sciences
Zip code
999077
Address
The Hong Kong Polytechnic University Hung Hom, Kowloon Hong Kong SAR, China
TEL
8613027936690
sherry-rui.she@polyu.edu.hk
Public contact
Name of contact person
| 1st name | Rui |
| Middle name | |
| Last name | She |
Organization
The Hong Kong Polytechnic University
Division name
Department of Rehabilitation Sciences
Zip code
999077
Address
The Hong Kong Polytechnic University Hung Hom, Kowloon Hong Kong SAR, China
TEL
8613027936690
Homepage URL
sherry-rui.she@polyu.edu.hk
Sponsor or person
Institute
The Hong Kong Polytechnic University
Institute
Department
Personal name
Funding Source
Organization
The study is supported by the Start-up Fund in the Hong Kong Polytechnic University
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
The Hong Kong Polytechnic University Department of Rehabilitation Sciences
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Hong Kong Polytechnic University
Address
The Hong Kong Polytechnic University Hung Hom, Kowloon Hong Kong SAR, China
Tel
(852) 3400-3635
RS.EthicsAdmin@polyu.edu.hk
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 06 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067136
